German Register of Outpatient Parenteral Antibiotic Therapy

NCT04413396 | Unknown

• 1 other identifier: OPATReg
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Many infectious diseases require a therapy that is administered intravenously due to a lack of oral treatments. Affected patients often have to stay weeks or even months in hospital just for receiving their therapy although they do not feel severely unwell. Outpatient parenteral antibiotic therapy (OPAT) allows these patients under certain requirements to get discharged from hospital and apply the antibiotic treatment on their own. For these patients quality of life improves by feeling more comfortable at home and being able to participate in everyday life or even go back to work. For the hospitals a reduced inpatient health care means a clear reduction of costs. The aim of OPATReg is to examine under which conditions the OPAT can be established at different locations of patient care. For this purpose, patients with APAT are to be treated and data collected at 7 university institutions in Germany. All centers have the expertise to provide comprehensive care for patients with infectious diseases, to transfer them from inpatient to outpatient care and to continue to provide care there. If successful, the project should help to identify the potential of OPAT for all of Germany. If positive effects and feasibility can be demonstrated OPAT could become an important therapy option with many advantages for certain patients.

Conditions

Implementation of OPAT in Germany

Outcome Measures

Primary Outcomes (3)

• Number of Patients with effective OPAT

  Successful administration and completion of the antiinfective therapy

  12 weeks

• Number of Patients With Treatment-Related Adverse Events

  side-effects of treatment and catheter-related infections

  12 weeks

• Number of Hospitals being able to apply OPAT

  Feasibility of OPAT under differing hospital specific circumstances

  12 weeks

Study Arms (1)

Outpatient parenteral antimicrobial therapy

Patients with an infectious disease that receive an outpatient parenteral antimicrobial therapy

Procedure: Outpatient Parenteral Antibiotic Therapy

Interventions

Outpatient Parenteral Antibiotic Therapy PROCEDURE

Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.

Outpatient parenteral antimicrobial therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults getting OPAT in one of the participating study sites

You may qualify if:

• patients who get OPAT

You may not qualify if:

• patients who don't get OPAT

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital of Cologne

Cologne, 50937, Germany

RECRUITING

Study Officials

• Clara Lehmann, Prof.

  Head of Outpatient Department in ID, University Hospital of Cologne

  STUDY CHAIR

Central Study Contacts

Clara Lehmann, Prof.

CONTACT

+4922147839684; clara.lehmann@uk-koeln.de

Charlotte Leisse

CONTACT

+4922147842895; charlotte.leisse@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of outpatient clinic

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 2, 2020
• Study Start: October 1, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

DE (1)